Export Regulatory Affairs Specialist

Full time posted 5 months ago in Regulatory
  • Cairo, 36 El Shiekh Mohamed El Nady St., Nasr City, 11371 View on Map
  • Post Date : January 12, 2025
  • Apply Before : January 23, 2025
  • 11 Application(s)
  • View(s) 606
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Job Detail

  • Job ID 16741
  • Career Level Entry Level/Junior Level / Fresh Grad
  • Experience (Min Years) 1
  • Experience (Max Years) 3
  • Age not less 22
  • Age not exceed 25
  • Education Level Bachelor\'s Degree
  • Gender All Gender
  • Industry Pharmaceutical
  • Nationality Egyptian

Job Description

  • Prepare and maintain required documentations needed for the registration of company products.
  • Coordinate with EDA; Egyptian Drug Authority, to ensure compliance with all regulations and laws as necessary, follow-up with submitted documentations and resolve any issued that may arise.
  • Prepare the registration documentations needed to register in different foreign countries in an effectively and timely manner.
  • Keep up-to-date with changes in regulatory legislation and guidelines and ensure company compliance with government rules and regulations.

Job Requirements:

Bachelor’s degree in Pharmacy is a must.

  • 1-3 years of experience in the pharmaceutical sector.
  • Expert in CTD files and e-CTD preparation and reviewing registration dossiers (countries specialized dossier or CTD).
  • Strong knowledge of the regulatory framework of international pharma legislation, relevant guideline, procedures &requirements.
  • Awareness of preparing submissions of license variations and renewals.
  • Proficiency in spoken and written English and prepared little French language.
  • Excellent communication and presentation skills.
  • Excellent Time management skills.
  • Problem solving and strategic planning skills.

Required skills

Communication Problem-solving Teamwork Time management

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